Findings from a Mini-Sentinel Medical Product Assessment: Influenza Vaccines and Risk of Febrile Seizures

Project Title Findings from a Mini-Sentinel Medical Product Assessment: Influenza Vaccines and Risk of Febrile Seizures
Date
Monday, July 21, 2014
Description

On July 21, 2014, the Engelberg Center for Health Care Reform at Brookings hosted a webinar, “Findings from a Mini-Sentinel Medical Product Assessment: Influenza Vaccines and Risk of Febrile Seizures.” This webinar provided an overview of a recent assessment that examined a possible association between use of certain trivalent inactivated influenza vaccines and febrile seizures in children. The results of the webinar will ultimately help to interpret the larger context of what is known about vaccines from various sources. The assessment will also enable Mini-Sentinel investigators to build general strategies to assess suspected associations of selected medical products and adverse events.

Presenters included Dr. Michael Nguyen, Deputy Director, Division of Epidemiology in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration; and Dr. Alison Kawai, Epidemiologist in the Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute.

Medical Product
13-valent pneumococcal vaccine (PCV13)
diphtheria, tetanus, acellular pertussis (DTaP) combination vaccine
diphtheria, tetanus, acellular pertussis (DTaP) vaccine
trivalent inactivated influenza vaccine (TIV)
Health Outcome
febrile seizure
Population / Cohort
All children 6 to 59 months of age
Time Period
2010 - 2011
Host

Gregory W. Daniel PhD, MPH; Evidence Development & Innovation, Engelberg Center for Health Care Reform, Brookings Institution, Washington DC

Data Sources
Mini-Sentinel Distributed Database (MSDD)
Location
Presenters

Michael Nguyen MD; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD 

Alison Kawai ScD, SM; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, boston, MA

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